Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap

Dvora L Joseph Davey; Linda-Gail Bekker; Elizabeth A Bukusi; Benjamin H Chi; Sinead Delany-Moretlwe; Ameena Goga; Anne Drapkin Lyerly; Nyaradzo M Mgodi; Nelly Mugo; Landon Myer; Lisa M Noguchi; Lynda Stranix-Chibanda; Catherine Slack; Jillian Pintye

doi:10.1016/S2352-3018(21)00280-0

Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap

Lancet HIV. 2022 Mar;9(3):e214-e222. doi: 10.1016/S2352-3018(21)00280-0. Epub 2022 Jan 25.

Authors

Affiliations

¹ Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles, CA, USA; Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, South Africa; The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa. Electronic address: dvoradavey@ucla.edu.
² The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
³ Centre for Microbiology Reseacrh, Kenya Medical Research Institute, Nairobi, Kenya; Department of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.
⁴ Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁵ Wits RHI, University of Witwaterstrand, Johannesburg, South Africa.
⁶ South African Medial Research Council, Cape Town, South Africa; Department of Paediatrics and Child Health, University of Pretoria, Pretoria, South Africa.
⁷ Department of Social Medicine and Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁸ Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.
⁹ Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya; Department of Global Health, University of Washington, Seattle, WA, USA.
¹⁰ Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, South Africa.
¹¹ Jhpiego, Johns Hopkins University, Baltimore, MD, USA.
¹² Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe; Child and Adolescent Health Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
¹³ School of Applied Human Sciences, University of KwaZulu Natal, Pietermaritzburg, South Africa.
¹⁴ Department of Global Health, University of Washington, Seattle, WA, USA.

Abstract

Pregnant and breastfeeding populations are at substantial risk of acquiring HIV in some settings, yet are underrepresented in clinical trials of new pre-exposure prophylaxis (PrEP) agents. Several PrEP formulations are in development (eg, vaginal rings, long-acting injectables, and other modalities). Pregnant and breastfeeding populations are typically excluded from initial clinical trials. We identified 14 PrEP trials of novel agents in non-pregnant or non-breastfeeding populations, and six phase 1-3 trials and open label extensions among pregnant and breastfeeding populations, that are currently ongoing or complete. A framework shift is needed to consider the ethical costs of excluding pregnant and breastfeeding populations at risk for HIV in PrEP clinical trials and promote inclusion to maximise the benefits from PrEP tools in the pipeline. Research on new PrEP agents should include pregnant and breastfeeding populations to avoid delays in reaching those who could benefit from PrEP after efficacy is established.

Publication types

Research Support, N.I.H., Extramural
Review

MeSH terms

Anti-HIV Agents* / therapeutic use
Breast Feeding
Female
HIV Infections* / drug therapy
HIV Infections* / prevention & control
Humans
Pre-Exposure Prophylaxis*
Pregnancy
Tenofovir / therapeutic use

Substances

Anti-HIV Agents
Tenofovir

Abstract

Publication types

MeSH terms

Substances

Grants and funding